osilodrostat

What is the most important information I should know about osilodrostat?

What is osilodrostat?

Osilodrostat is used in adults to treat Cushing's disease that cannot be treated with pituitary surgery.

Osilodrostat may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before taking osilodrostat?

Tell your doctor if you have ever had:

• a heart rhythm disorder;
• long QT syndrome (in you or a family member);
• congestive heart failure;
• high blood pressure;
• an electrolyte imbalance (such as low levels of potassium or magnesium in your blood);
• fluid retention; or
• liver disease.

Tell your doctor if you are pregnant or plan to become pregnant. It is not known whether osilodrostat will harm an unborn baby. However, having Cushing's disease during pregnancy may cause complications such as diabetes or eclampsia (dangerously high blood pressure that can lead to medical problems in both mother and baby). The benefit of treating Cushing's disease may outweigh any risks to the baby.

How should I take osilodrostat?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

You may take osilodrostat with or without food.

Your doctor will check your heart function using an electrocardiograph or ECG (sometimes called an EKG). Your next dose may be delayed based on the results of your ECG or other medical tests.

Do not change your dose or dosing schedule without your doctor's advice.

What happens if I miss a dose?

Skip the missed dose and use your next dose at the regular time. Do not use two doses at one time.

What happens if I overdose?

Overdose symptoms may include nausea, vomiting, stomach pain, extreme tiredness, feeling light-headed, or fainting.

What should I avoid while taking osilodrostat?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

What are the possible side effects of osilodrostat?

• fast or pounding heartbeats, fluttering in your chest, shortness of breath, and sudden dizziness (like you might pass out);
• swelling in your feet or ankles, feeling short of breath;
• decreased adrenal gland hormones --nausea, vomiting, stomach pain, loss of appetite, feeling tired or light-headed, muscle or joint pain, skin discoloration, craving salty foods;
• increased adrenal gland hormones --hunger, weight gain, swelling, skin discoloration, slow wound healing, sweating, acne, increased body hair, tiredness, mood changes, muscle weakness, missed menstrual periods, sexual changes; or
• low potassium level --leg cramps, constipation, irregular heartbeats, fluttering in your chest, increased thirst or urination, numbness or tingling, muscle weakness or limp feeling.

Common side effects may include:

• nausea;
• feeling tired;
• headache; or
• swelling.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect osilodrostat?

Other drugs may affect osilodrostat, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Where can I get more information?

Your pharmacist can provide more information about osilodrostat.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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